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EU Medical Device Classification

According to EU MDR 2017/745, Article 51 of the medical device classification categorizes into classes I, IIa, IIb, and III, considering their intended purposes and their inherent risks. The risk is incremental from class 1 to class III.

 

The MDD and MDR both use a rule-based medical device classification pattern. In the new MDR, there are now 22 rules in Annex VIII.

 

The determination of the EU classification and the corresponding rule is the first step in the EU CE marking process. Based on the class and the rule of the device, the technical file and the Notified Body application can be filed.

I3CGLOBAL successfully completed 300+ CE certifications worldwide by supporting manufacturers with EU medical device classification of simple and complex device technologies for faster Notified body approval. We have offices in India, Europe, and the USA to help with classification and technical documentation.

EU Medical Device Classification Examples

Class 1 - Low Risk

  • Examples: corrective glasses and frames; manual wheelchairs
  • Type of Certification: Self-Certification or Self-Declaration

Class 1s Low Risk (Sterile)

  • Examples: personal protection kits, sterile urine bags, etc.
  • Type of Certification: Notified Body

Class 1m Low Risk (Measuring Body attributes)

  • Examples: stethoscopes, weighing balance
  • Type of Certification: Notified Body

Class 1r Low Risk ( Reused Device)

  • Examples: Surgical forceps (all types of SS/TIT surgical equipment sterilized and reused by hospitals)
  • Type of Certification: Notified Body

Class IIa - Medium Risk

  • Examples: orthodontic wires, surgical gloves, lancets
  • Type of Certification: Notified Body

Class IIb - Medium to High Risk

  • Examples: orthopedic nails and plates; intra-ocular lenses; incubators for babies
  • Type of Certification: Notified Body

Class III - High Risk

  • Examples: pacemakers, prosthetic heart valves, cardiovascular sutures, brain spatulas, drug-device combination products
  • Type of Certification: Notified Body

Medical Device Classification Rules

As per Annex VIII of the Medical Device Classification Rules, they are as follows:

 

  • Rules 1–4: Non-invasive Devices
  • Rules 5–8: Invasive Devices
  • Rules 9–13: Active Devices
  • Rules 14–22: Special Rules

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